MHRA-100868-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • AFAMELANOTIDE
Invented Name
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
PIP Number MHRA-100868-PIP01-23-M01 (update)
Pharmaceutical form(s)
  • Implant
  • Age appropriate prolonged release formulation
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of erythropoietic protoporphyria (EPP)
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
  • CLINUVEL (UK) LIMITED
  • Country United Kingdom
  • Tel +61396604900
  • Email mail@clinuvel.com
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):AFAMELANOTIDE.pdf
Published Date 19/12/2023